MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Low Blood Pressure/ Hypotension (1914); Staphylococcus Aureus (2058); Vomiting (2144); Loss of consciousness (2418)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving gablofen (500mcg/ml at 50mcg/day) via intrathecal drug delivery pump.The indication for use was not noted.It was reported that the patient had been vomiting pos operation.No environmental, external, or patient factors were reported to have caused this issue.It was unknown what would be done at this time.The devices were implanted on (b)(6) 2019.The issue was not resolved and the patient was "alive - no injury." there were no further complications reported at this time.Additional information was received from the consumer and manufacturer¿s representative (rep) on (b)(6) 2019.The reason for use was intractable spasticity and spinal cord injury/spinal cord disease.It was reported that this patient had an itb trial with 50ug and it was successful so the drug infusion system was implanted on (b)(6) 2019 (previously reported as (b)(6) 2019).Two days later, the patient began vomiting but then got better.Yesterday ((b)(6) 2019) the patient went to physical therapy.Today ((b)(6) 2019) they collapsed/passed out at home and was brought to the emergency department.The rep was inquiring what the issue may be for this patient and if there were any programming mistakes made.During the call, they troubleshooted with the caller and reviewed pertinent information per the caller's inquires.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.It was unknown what interventions/actions that were taken to resolve the issue.It was unknown if surgical intervention was planned.The issue was not resolved at the time of the report.There were no further complications reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer¿s representative (rep) regarding an implantable drug infusion device.The drug being delivered was 500 mcg/ml lioresal (baclofen) at 50 mcg/day.It was reported that shortly after implantation and implementation of intrathecal lioresal ((b)(6) 2019), the patient developed hypotension.The patient was evaluated but they were unsure of the cause.The patient was seen again on (b)(6) 2019 for a dosing change (unsure to what dose).On (b)(6) 2019, the family notified the rep that they had called 911 because the patient was hypotensive again.The patient was on the way to the hospital at the time of the report.The change in therapy/symptoms was noted as ¿sudden.¿ there were no further complications reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: catheter.Product id: 8780, se rial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.It was reported that the hypotension was a result of the patient being septic with (b)(6).The pump and catheter were explanted on (b)(6) 2019 and there was pus in the cerebrospinal fluid (csf) and around the catheter.There were no further complications reported at this time.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.It was reported that now that they explanted and saw the pus, they believed the previously reported symptoms of vomiting and collapsed/passed out at home were related to the sepsis.There were no further complications reported at this time.Additional information was received from a manufacturer representative.It was reported that at the facility where the patient was implanted, they only used gablofen.The patient was receiving gablofen.There were no further complications reported at this time.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8270411
• MDR Text Key: 133848288
• Report Number: 3004209178-2019-01510
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Date Device Manufactured: 06/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR